COMMISSION - Transportstyrelsen

II(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 30 May 2002

concerning the technical specification for interoperability relating to the maintenance subsystemof the trans-European high-speed rail system referred to in Article 6(1) of Directive 96/48/EC

(Notified under document number C(2002) 1946)

(Text with EEA relevance)

(2002/730/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the EuropeanCommunity,

Having regard to Council Directive 96/48/EC of 23 July 1996on the interoperability of the trans-European high-speed railnetwork (1), and in particular Article 6(1) thereof,

Whereas:

(1) In accordance with Article 2(c) of Directive 96/48/EC,the trans-European high-speed rail system is subdividedinto structural or functional subsystems. Thesesubsystems are described in Annex II to the Directive.

(2) In accordance with Article 5(1) of the Directive, each ofthe subsystems shall be covered by a technicalspecification for interoperability (TSI).

(3) In accordance with Article 6(1) of the Directive, draftTSIs shall be drawn up by the joint representative body.

(4) The Committee set up under Article 21 of Directive96/48/EC has appointed the European Association forRailway Interoperability (AEIF) as the jointrepresentative body in accordance with Article 2(h) ofthe Directive.

(5) The AEIF has been given a mandate to draw up a draftTSI for the maintenance subsystem in accordance withArticle 6(1) of the Directive. This mandate has beenestablished in accordance with the procedure laid downin Article 21(2) of the Directive.

(6) The AEIF has drawn up the draft TSI, together with anintroductory report containing a cost-benefit analysis asprovided for in Article 6(3) of the Directive.

(7) The draft TSI has been examined by the representativesof the Member States, in the framework of theCommittee set up by the Directive, in the light of theintroductory report.

(8) As specified in Article 1 of Directive 96/48/EC, theconditions for achieving interoperability of thetrans-European high-speed rail system concern thedesign, construction, upgrading and operation of theinfrastructures and rolling stock contributing to thefunctioning of the system to be put into service afterthe date of entry into force of the Directive. With regardto the infrastructures and rolling stock already in serviceat the time of entry into force of this TSI, the TSIshould be applied from the time when work isenvisaged on these infrastructures and rolling stock.However, the degree to which the TSI is applied willvary according to the scope and extent of the worksforeseen and the costs and the benefits generated by theintended applications. In order for such partial works toconcur into achieving full interoperability, they need tobe underpinned by a coherent implementation strategy.In this context, a distinction should be made betweenupgrading, renewal and maintenance-relatedreplacement.(1) OJ L 235, 17.9.1996, p. 6.

12.9.2002 L 245/1Official Journal of the European CommunitiesEN

(9) It is recognised that Directive 96/48/EC and the TSIs donot apply to renewals or maintenance-relatedreplacement. It is desirable however that the TSIs shouldapply to renewals, as will be the case for the TSIs forthe conventional rail system under Directive of theEuropean Parliament and of its Council 2001/16/EC (2).In the absence of a mandatory requirement and takinginto account the extent of the renewal work, MemberStates are encouraged, where they are able to do so, toapply the TSIs to renewals and maintenance-relatedreplacement.

(10) The TSI, which is the subject of this Decision, does notimpose the use of specific technologies or technicalsolutions except where this is strictly necessary for theinteroperability of the trans-European high-speed railnetwork.

(11) The TSI, which is the subject of this Decision, is basedon best available expert knowledge at the time ofpreparation of the corresponding draft. Developments intechnology or social requirements may make itnecessary to amend or supplement this TSI. Whereappropriate, a review or updating procedure will beinitiated in accordance with Article 6(2) of Directive96/48/EC.

(12) The provisions concerning maintenance specific to eachsubsystem and those concerning degraded modes are setout in the corresponding TSIs. The maintenance TSItherefore only concerns questions relating to logisticscentres for train maintenance.

(13) In some cases, the TSI, which is the subject of thisDecision, allows a choice between different solutions,making it possible to apply definitive or transitionalinteroperable solutions that are compatible with theexisting situation. In addition, Directive 96/48/ECprovides for special implementing provisions in certainspecific cases. Furthermore, in the cases provided for inArticle 7 of the Directive Member States must beallowed not to apply certain technical specifications. Itis therefore necessary that the Member States ensurethat an infrastructure register and a rolling stock registerare published and updated each year. These registerswill set out the main characteristics of the nationalinfrastructure and rolling stock (e.g. the basicparameters) and their concordance with thecharacteristics prescribed by the applicable TSIs. To thisend, the TSI, which is the subject of this Decision,indicates precisely which information must appear inthe registers.

(14) The application of the TSI which is the subject of thisDecision must take into account specific criteria relatingto technical and operational compatibility between theinfrastructures and the rolling stock to be placed inservice and the network into which they are to beintegrated. These compatibility requirements entail acomplex technical and economical analysis that is to bedone on a case by case basis. The analysis should takeinto account:

� the interfaces between the different subsystemsreferred to in Directive 96/48/EC,

� the different categories of lines and rolling stockreferred to in that Directive, and

� the technical and operational environments of theexisting network.

That is why it is essential to establish a strategy for theimplementation of the TSI which is the subject of thisDecision, which should indicate the technical stages tomove from the present network conditions to asituation where the network is interoperable.

(15) The provisions of this Decision are in conformity withthe opinion of the Committee set up by Directive96/48/EC,

HAS ADOPTED THIS DECISION:

Article 1

The TSI relating to the �maintenance� subsystem of thetrans-European high-speed rail system referred to in Article6(1) of Directive 96/48/EC is hereby adopted by theCommission. The TSI is set out in the Annex to this Decision.The TSI is fully applicable to the infrastructure and rollingstock of the trans-European high-speed rail system as definedin Annex I of Directive 96/48/EC, taking into account Article2 hereunder.

Article 2

1. For the purposes of this Article:

� �upgrading� means major work to modify a subsystem orpart of a subsystem which changes the performance of thesubsystem,

� �renewal� means major work to replace a subsystem or partof a subsystem which does not change the performance ofthe subsystem,(2) OJ L 110, 20.4.2001, p. 1.

L 245/2 12.9.2002Official Journal of the European CommunitiesEN

� �maintenance-related replacement� means replacement ofcomponents by parts of identical function andperformances in the context of predictive or correctivemaintenance.

2. In the case of upgrading, the contracting entity willsubmit a dossier describing the project to the Member Stateconcerned. The Member State will examine the dossier and,taking into account the implementation strategy in Chapter 7of the attached TSI, will (where appropriate) decide whetherthe application of the attached TSI is needed. If so, it willinform the Committee set up pursuant to Directive 96/48/EC.

3. In the case of renewal and maintenance-relatedreplacement, application of the attached TSI is voluntary.

Article 3

The attached TSI shall enter into force six months afternotification of this Decision.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 30 May 2002.

For the CommissionLoyola DE PALACIO

Vice-President


ANNEX

TECHNICAL SPECIFICATION FOR INTEROPERABILITY RELATING TO THE MAINTENANCE SUBSYSTEM

1. INTRODUCTION

1.1. TECHNICAL SCOPE

This TSI concerns the maintenance subsystem, which is one of the subsystems listed in Annex II.1 to Directive96/48/EC.

This TSI is part of a set of six TSIs, which cover all the eight subsystems defined in the Directive. The specificationsconcerning the �users� and �environment� subsystems, which are necessary to ensure interoperability of thetrans-European high-speed rail system in compliance with the essential requirements, are set out in the TSIs concerned.

More information about the maintenance subsystem is given in Chapter 2.

1.2. GEOGRAPHICAL SCOPE

The geographical scope of this TSI is the trans-European high-speed rail system as described in Annex I to Directive96/48/EC.

Reference shall be made in particular to the lines of the trans-European rail network described in European Parliamentand Council Decision No 1692/96/EC of 23 July 1996 on Community guidelines for the development of thetrans-European transport network or in any update to the same Decision as a result of the revision provided for inArticle 21 of that Decision.

1.3. CONTENT OF THIS TSI

In accordance with Article 5(3) and with Annex I, point 1(b) to Directive 96/48/EC, this TSI:

(a) specifies the essential requirements for the subsystems and their interfaces (Chapter 3);

(b) establishes the basic parameters described in Annex II, point 3 to that Directive, which are necessary to meet theessential requirements (Chapter 4);

(c) establishes the conditions to be complied with to achieve the specified performances for each of the followingcategories of line (Chapter 4):

� category I: specially built high-speed lines equipped for speeds generally equal to or greater than 250 km/h,

� category II: specially upgraded high-speed lines equipped for speeds of the order of 200 km/h,

� category III: specially upgraded high-speed lines which have special features as a result of topographical, reliefor town-planning constraints, on which the speed must be adapted to each case.

(d) establishes implementing provisions in certain specific cases (Chapter 7);

(e) determines the interoperability constituents and interfaces which must be covered by European specifications,including European standards, which are needed in order to achieve interoperability within the trans-Europeanhigh-speed rail system while meeting the essential requirements (Chapter 5):

(f) states, in each case under consideration, which of the modules defined in Decision 93/465/EEC or, whereappropriate, which specific procedures are to be used in order to assess either the conformity or the suitability foruse of the interoperability constituents, as well as �EC� verification of the subsystems (Chapter 6).

2. SUBSYSTEM DEFINITION AND SCOPE

The aim of this technical specification is to define the technical and regulatory prescriptions together with the necessaryand appropriate procedures for the constituents in the �maintenance� subsystem and for the interfaces required toguarantee interoperability of the European high-speed network in compliance with the essential requirements of the�maintenance� subsystem.


The definition of the domain concerned by the maintenance subsystem together with the field of application of theassociated technical specification are derived from the maintenance or monitoring operations which should be appliedas general practice in order to meet the requirements of interoperability.

In view of the geographical structure of the European high-speed network and the commercial speeds at which trainsare operated, it will be possible to schedule rosters so that each train can return at staggered intervals to a designatedbase in its country of origin where the complex maintenance operations will be carried out at frequencies compatiblewith the design and reliability of high-speed trains. Indeed, the design of high-speed trains integrates highly reliabletechnical solutions and functional architecture incorporating redundancy with a very high level of availability which isfar superior to a conventional rake of coaches with one or two locomotives. In addition, monitoring or testing deviceswhich use automatic isolation equipment make it easier to identify the current functional status of the trainset so that itcan be formed in such a way as to continue in commercial service until its return to the maintenance centre.

The conditions under which some repair work can be undertaken to allow the safe return of the rolling stock to theagreed maintenance depot and the special operating conditions for the rolling stock when it is in a degraded state, shallbe agreed, case by case, between the infrastructure managers and the railway undertakings, according to particularcharacteristics of the rolling stock and to the circulation rules or regulations of the countries concerned.

In no event must any major corrective maintenance operation (except those required by specific situations, see Annex Ito this TSI) or inspection be performed outside the dedicated trainset maintenance facilities. As a result, trainsetmaintenance logistics facilities covered by the present TSI shall be expressly restricted to operations ensuringinteroperability. Such operations concern the restocking of consumable materials (water and sand), cleaning (the insideand outside of trainsets) and toilet emptying.

Generally speaking, maintenance arrangements specific to each subsystem covered by a TSI shall, if necessary at all, beset out in the corresponding TSI.

As regards the reliability and functional architecture of trainsets as well as the maintenance organisation used,maintenance is organised so as to be compatible with economically acceptable and profitable trainset operation.

From this standpoint, facilities falling within the field of application of the �maintenance� technical specification forinteroperability (TSI) are those required to:

� clean the inside and outside of the trainsets,

� deal with retention toilets,

� restock the water and sand supplies.

3. ESSENTIAL REQUIREMENTS

3.1. In accordance with Article 4(1) of Directive 96/48/EC, the trans-European high-speed rail system, itssubsystems and their interoperability constituents must meet the relevant essential requirements as specifiedin Annex III to the Directive.

3.2. The essential requirements are related to:

� safety,

� reliability and availability,

� health,

� environmental protection,

� technical compatibility.

According to Directive 96/48/EC, the essential requirements may be general in scope and are applicableacross the board to the entire trans-European high-speed rail system and may contain specific features foreach subsystem and its constituents.


3.3. Requirements specific to the �maintenance� subsystem (facilities and procedures used in maintenance centreshandling interoperable high-speed trainsets) responding to and in addition to the considerations laid downin Annex III to the Directive are specified as follows:

� Safety

Essential requirement 1.1.1:

�The design, construction or assembly, maintenance and monitoring of safety-critical components, and moreparticularly of the components involved in train movements must be such as to guarantee safety at thelevel corresponding to the aims laid down for the network, including those for specific degraded situations.�

The fulfilment of this essential requirement may be considered as achieved when conformity to theprescriptions of point 4.2.2.2.5 (sand restocking equipment) of the present TSI is certified.


�The parameters involved in the wheel/rail contact must meet the stability requirements needed in order toguarantee safe movement at the maximum authorised speed.�

This essential requirement is not relevant to the maintenance subsystem.


�The components used must withstand any normal or exceptional stresses that have been specified duringtheir period in service. The safety repercussions of any accidental failures must be limited by appropriatemeans.�



�The design of fixed installations and rolling stock and the choice of the materials used must be aimed atlimiting the generation, propagation and effects of fire and smoke in the event of a fire.�

For the fixed installations of the maintenance subsystem, the fulfilment of this essential requirement may beconsidered as achieved when conformity of these installations with national regulations is demonstrated.


�Any devices intended to be handled by users must be so designed as not to impair their safety if usedforeseeably in a manner not in accordance with the posted instructions.�

This essential requirement is not relevant to the �maintenance� subsystem.

� Reliability and availability

Essential requirement 1.2:

�The monitoring and maintenance of fixed or movable components that are involved in train movementsmust be organised, carried out and quantified in such a manner as to maintain their operation under theintended conditions.�

High-speed trainsets incorporate high-reliability technical solutions and functional architectural featureswith built-in redundancy ensuring maximum trainset availability. In addition monitoring/control equipmentcombined with automatic-isolation systems makes easier the knowledge of the functional status of trainsetsand enables them to be configured in a way that guarantees continued operation of the trainset incommercial service until its return to the maintenance depot.

Consequently no specific measure needs to be taken with regard to the �maintenance� subsystem to ensuretrainset reliability and availability in the context of this essential requirement.


� Health


�Materials likely, by virtue of the way they are used, to constitute a health hazard to those having access tothem must not be used in trains and railway infrastructures.�

For the fixed installations of the maintenance subsystem, the fulfilment of this essential requirement may beconsidered as achieved when conformity of these installations with EC Directives and national regulations isdemonstrated.


�Those materials must be selected, deployed and used in such a way as to restrict the emission of harmfuland dangerous fumes or gases, particularly in the event of fire.�



�The technical installations and the procedures used in the maintenance centres must not constitute adanger to human health.�

For the fixed installations of the �maintenance� subsystem, the fulfilment of this essential requirement maybe considered as achieved when conformity of these installations with national regulations is demonstrated.

� Environmental protection


�The repercussions on the environment of the establishment and operation of the trans-Europeanhigh-speed rail system must be assessed and taken into account at the design stage of the system inaccordance with the Community provisions in force.�

This essential requirement is not relevant to the �maintenance� subsystem.


�The materials used in the trains and infrastructures must prevent the emission of fumes or gas which areharmful and dangerous to the environment, particularly in the event of fire.�



�The rolling stock and energy-supply systems must be designed and manufactured in such way as to beelectromagnetically compatible with the installations, equipment and public or private networks with whichthey might interfere.�



�The technical installations and the procedures used in the maintenance centres must not exceed thepermissible levels of nuisance with regard to the surrounding environment.�



� Technical compatibility

Essential requirement 1.5:

�The technical characteristics of the infrastructures and fixed installations must be compatible with eachother and with those of the trains to be used on the trans-European high-speed rail system.

If adherence to these characteristics proves difficult on certain sections of the network, temporary solutions,which ensure compatibility in the future, may be implemented.�

The fulfilment of this essential requirement may be considered as achieved when conformity to theprescriptions of points 4.2.2.1, 4.2.2.2.1, 4.2.2.2.2 and 4.2.2.2.4 of Chapter 4, as well as points 5.3.1 and5.3.5 of Chapter 5 of the present TSI is certified.


�The maintenance installations (handling) high-speed trains must be such as to enable safety, health andcomfort operations to be carried out on all trains for which they have been designed.�

The fulfilment of this essential requirement may be considered as achieved when conformity to theprescriptions of points 4.2.2.1, 4.2.2.2.1, 4.2.2.2.2, 4.2.2.2.4, 4.2.2.2.5 and 4.2.2.2.6 of Chapter 4, as wellas points 5.3.1 and 5.3.5 of Chapter 5 of the present TSI is certified.

3.4. Verification that the essential requirements governing the subsystem and its constituents have beencomplied with is established in accordance with the provisions laid down in Directive 96/48/EC.

4. CHARACTERISATION OF THE SUBSYSTEM

The high-speed trans-European rail system as covered by the provisions of Directive 96/48/EC and of which themaintenance subsystem forms a part, is an integrated system the coherence of which must be verified particularlyregarding the basic parameters, the interfaces and the performance levels with a view to ensuring systeminteroperability in the respect of the essential requirements.

Regarding interoperability, the maintenance subsystem is characterised as follows:

4.1. BASIC PARAMETERS OF THE �MAINTENANCE� SUBSYSTEM

The maintenance subsystem is not characterised by the basic parameters listed in Annex II (Section 3) toDirective 96/48/EC.

4.2. INTERFACES OF MAINTENANCE SUBSYSTEM

4.2.1. Subsystem interface

Regarding technical compatibility, the interfaces of the maintenance subsystem are concerned with:

� the infrastructure subsystem,

� the rolling stock subsystem.

4.2.2. These interfaces are characterised by:

4.2.2.1. Interface with the infrastructure subsystem

� Stabling tracks

� Stabling tracks must have an overhead line to supply power to the train.

� Their geometrical characteristics (including length) have to be in accordance with the prescriptionsof point 4.3.3.5 of the infrastructure TSI.

� If a toilet discharge trolley is used, the minimum distance between track centres must be 6 m anda running path for the trolleys shall be provided.


4.2.2.2. Interface with the rolling stock subsystem

4.2.2.2.1. T r a i n s e t e x t e r i o r c l e a n i n g f a c i l i t i e s

� It must be possible for the front windows of drivers' cabs to be cleaned both from the ground andfrom platform heights of 550 mm and 760 mm using suitable (with particular regard to health andsafety aspects) cleaning equipment, in all stations and facilities at which the trains call or are stabled.

� When washing machines are used they shall be able to clean the outer sides of single or double-decktrainsets over a height of:

� 1 000 to 3 500 mm for a single-deck trainset,

� 500 to 4 300 mm for double-deck trainsets.

It must be possible for the speed at which the trainset passes through the train washing plant to beadapted to suit each washing plant, i.e. between 4 and 6 km/h.

� Products used for washing trains must comply with local environmental-protection regulations.

4.2.2.2.2. T o i l e t d i s c h a r g e s y s t e m s

� The technology of the trainset toilets shall allow the sealed toilets (using clear or recycled water) to beemptied at three-day intervals, so that the emptying operations can be performed on a scheduled basisat designated depots.

� Toilets discharge installation (fixed or mobile) shall be compatible with the characteristics either of oneof the sealed system either with the other one.

� A mobile trolley may be provided to enable evacuation when needed thereby allowing the rolling stockto continue in commercial service until its return to the home depot.

� Any mobile discharge trolleys needed shall perform all of the following functions:

� suction (the limit value for the suction vacuum is set at 0,2 bar),

� rinsing (only applies to retention toilet discharge equipment),

� pre-loading or filling with additive (only applies to retention toilet discharge equipment),

� discharge.

4.2.2.2.3. T r a i n s e t i n t e r i o r c l e a n i n g e q u i p m e n t

� A 3 000 VA at 230 V, 50 Hz electrical power supply connection shall be provided in each coach forpowering industrial cleaning equipment. This power must be available simultaneously in all the coachesof a trainset. Electric power sockets inside the train must be spaced such that no part of the coach thatmust be cleaned is more than 12 m from one of the sockets.

4.2.2.2.4. W a t e r r e s t o c k i n g e q u i p m e n t

� The new equipment for water supply on the interoperable network shall be supplied with drinkingwater in accordance with Directive 98/83/EC, and their mode of operation must ensure that waterdelivered at the last element of the fixed part of these installations complies with the quality specifiedby this same Directive for water intended for human consumption.

4.2.2.2.5. S a n d r e s t o c k i n g e q u i p m e n t

� Sandboxes are normally filled during scheduled maintenance operations in specialised workshops incharge of trainset maintenance. However, if required, sand meeting local specifications for this use shallbe made available to fill sand boxes so that rolling stock can continue in commercial service until itreturns to its maintenance centre.


4.2.2.2.6. S p e c i a l r e q u i r e m e n t s f o r s t a b l i n g o f t r a i n s

The trains must be designed so that:

� the trainsets respect, during their stabling, the level of noise stipulated in the rolling stock TSI,

� periodic monitoring is not necessary when they are stabled under voltage,

� they can be configured for different functional levels (standby, preparation, etc.),

� an absence of voltage does not damage any train constituents,

� stabled trains can be safely secured against all risks of unexpected movement.

They must in particular incorporate parking brakes to ensure that operating rules applicable locally can beobserved whenever the use of such brakes is required.

4.2.3. Regulatory and operational provisions

To ensure coherence of the trans-European railway system, the abovementioned interfaces shall be subjectto the following regulatory and operational requirements:

(None)

4.3. SPECIFIED PERFORMANCE OF THE MAINTENANCE SUBSYSTEM

The performance criteria which the maintenance subsystem must meet correspond to the performancesspecified for each of the following line categories of the trans-European high-speed rail system, as relevant:

� lines specially built for high-speed running,

� lines specially upgraded for high speed,

� lines specially upgraded for high speed which have special features.

In the case of the maintenance subsystem, the performance requirements are the same for all threecategories of line.

5. INTEROPERABILITY CONSTITUENTS

5.1. In keeping with Article 2(d) of Directive 96/48/EC, interoperability constituents are �any elementarycomponent, group of components, subassembly or complete assembly of equipment incorporated orintended to be incorporated into a subsystem, upon which the interoperability of the trans-Europeanhigh-speed rail system depends either directly or indirectly�.

5.2. The interoperability constituents are subject to relevant provisions in Directive 96/48/EC and are thefollowing as concerns this TSI:

� toilet discharge systems: connections,

� equipment for cleaning trainset interiors: electrical sockets,

� equipment for restocking of water and sand supplies: water filling (inlet) adapters.

5.3. These interoperability constituents are the subject of specifications in the form of performancerequirements. Conformity assessment and/or fitness for use is focused through interoperability constituentinterface requirements as a priority, with reference to design or descriptive characteristics being exceptional.


5.3.1. The specifications for the toilet discharge system connections interoperability constituent are the following:

� The connections (3'' for emptying and 1'' for rinsing) and their seals must comply with figures 1 and 2respectively of Annex IV.

5.3.2. The interfaces of the toilet discharge system connections interoperability constituent are characterised asfollows:

(None)

5.3.3. The specifications for the trainset interior cleaning equipment, electrical sockets interoperability constituentare the following:

� The interior sockets must comply with the dimensions laid down in EN Standard 60 309.1, and mustfulfil the dimensional characteristics of the socket stated on page 22 of EN Standard 60 309.2 (socketwith two poles + earth) and the characteristics specified in Sections 8.3.1 and 8.3.1.1 of Standard EN50 153.

5.3.4. The interfaces of the trainset interior cleaning equipment, electrical sockets interoperability constituent arecharacterised as follows:

(None)

In as much as the specifications of the interoperability constituent trainset interior cleaning equipment,electrical sockets make reference to European specifications drawn up by the European standardisationbodies � CEN, CENELEC and ETSI � as instructed by the Commission, the latter specifications themselvesmust be drawn up on a performance basis and only exceptionally on a prescriptive basis.

The relevant European specifications are:

� Standard EN 60 309.1,

� Standard EN 60 309.2 (p. 22),

� Standard EN 50 153 (Section 8.3.1 and 8.3.1.1),

� Directive 98/83/EC (quality of the water).

5.3.5. The specifications of the interoperability constituent water filling adapters are the following:

� The water filling adapters shall be as shown in Figure 3 of Annex V.

5.3.6. The interfaces of the water filling adapters interoperability constituent are characterised as:

(None).

6. ASSESSMENT OF CONFORMITY AND/OR SUITABILITY FOR USE

6.1. INTEROPERABILITY CONSTITUENTS

6.1.1. Conformity assessment procedures (modules)

The assessment procedure for conformity of interoperability constituents as defined in Chapter 5 of this TSIshall be carried out by application of modules as specified in Annex III to this TSI.

Assessment procedures for conformity, descriptions of the testing methods for in the interoperabilityconstituents: toilet discharge system connections, trainset interior cleaning equipment (electrical sockets)and water filling adapters, as defined in Chapter 5 of this TSI, are indicated in Annex II, Tables II.1, II.2 andII.3 to this TSI.


As far as required by the modules specified in Annex III to this TSI, the assessment of conformity of aninteroperability constituent shall be appraised by a notified body, when indicated in the procedure, withwhich the manufacturer or his authorised representative established within the Community has lodged theapplication.

The manufacturer of an interoperability constituent or his authorised representative established within theCommunity shall draw up an EC declaration of conformity in accordance with Article 13(1) and Annex IV,Chapter 3, to Directive 96/48/EC before placing the interoperability constituent on the market. An ECdeclaration of suitability for use is not required for interoperability constituents of the maintenancesubsystem.

6.1.2. Application of modules

Assessment of conformity

For the assessment procedure of each interoperability constituent of the maintenance subsystem, themanufacturer or his authorised representative established within the Community shall apply the internalcontrol of production procedure (module A) indicated in Annex III (III.1) to this TSI.

Definition of assessment procedures

The assessment procedures are defined in Annex III to this TSI.

The conformity assessment shall cover the phases and characteristics as indicated by X in the Tables II.1,II.2 and II.3 of Annex II to this TSI.

6.2. MAINTENANCE SUBSYSTEM

6.2.1. Assessment procedures (modules)

At the request of the adjudicating entity or its authorised representative established within the Community,the notified body carries out the EC verification in accordance with Article 18(1) and Annex VI to Directive96/48/EC and in accordance with the provisions of the relevant modules as specified in Annex III to thisTSI.

If the adjudicating entity can demonstrate that tests or verifications for previous applications remain validin the new application, then the notified body shall take them into account in the conformity assessment.

Assessment procedures for the EC verification of the maintenance subsystem, list of specifications anddescriptions of the testing procedures are indicated in Annex II, Table II.4 to this TSI.

As far as specified in this TSI, the EC verification of the maintenance subsystem shall take account of itsinterfaces with other subsystems of the trans-European high-speed rail system.

The adjudicating entity shall draw up the EC declaration of verification for the maintenance subsystem inaccordance with Article 18(1) and Annex V to Directive 96/48/EC.

6.2.2. Application of modules

6.2.2.1. Fixed installations

For the verification procedure of the maintenance subsystem (fixed installations), the adjudicating entity orits authorised representative established within the Community may choose either:

� the unit verification procedure (module SG) indicated in Annex III (III.5) to this TSI, or

� the full quality assurance with design examination procedure (module SH2) indicated in Annex III (III.6)to this TSI.

The module SH2 may be chosen only where all activities contributing to the subsystem project to beverified (design, manufacturing, assembling, installation) are subject to a quality system for design,production, final product inspection and testing, approved and surveyed by a notified body.

The assessment shall cover the phases and characteristics as indicated in Table II.4 of Annex II to this TSI.


6.2.2.2. On-board installations

For the verification procedure of the maintenance subsystem (on-board installations), the adjudicating entityor its authorised representative established within the Community may choose either:

� the type-examination procedure (module SB) indicated in Annex III (III.2) to this TSI, for the design anddevelopment phase, in combination with:

� either the production quality assurance procedure (module SD) indicated in Annex III (III.3), or theproduct verification procedure (module SF) indicated in Annex III (III.4) to this TSI, for the productionphase, or

� the full quality assurance with design examination procedure (module SH2) indicated in Annex III (III.6)to this TSI, for all phases.

The module SD may be chosen only where all activities contributing to the subsystem project to be verified(manufacturing, assembling, installation) are subject to a quality system for production, final productinspection and testing, approved and surveyed by a notified body.

The module SH2 may be chosen only where all activities contributing to the subsystem project to beverified (design, manufacturing, assembling, installation) are subject to a quality system for design,production, final product inspection and testing, approved and surveyed by a notified body.

The assessment shall cover the phases and characteristics as indicated in Table II.5 of Annex II to this TSI.

7. IMPLEMENTING THE MAINTENANCE TSI

7.1. IMPLEMENTATION PROCEDURE AND TIMING

7.1.1. Procedure

The implementation of the specifications on maintenance equipment are based on the following generalsteps:

Step 1:

The rolling stock roster project is examined by both the infrastructure manager and the railwayundertaking.

Step 2:

An economic study is carried out by both the infrastructure manager and the railway undertaking, on thebasis of which the initial roster may be modified.

7.1.2. Timing

Because of:

� the time needed to build or modify the fixed installations, and to put into place the mobile toiletdischarge trolleys,

� the principle by which compliance with interoperability requirements of the already existing fixedinstallations is only possible if incorporated into long-term renewal and repair schedules,

the timing of implementation will have to be negotiated between the infrastructure manager and therailway undertaking.

In particular, if the railway undertaking wishes to start to operate the interoperable route within a time notcompatible with those constraints, then the infrastructure manager and the railway undertaking willnegotiate temporary solutions (drawing up temporary rolling stock rosters for example).


7.1.3. Implementation of maintenance equipment (lines of all categories)

7.1.3.1. Stabling tracks

First step: the infrastructure manager and the railway undertaking examine together the rolling stock rosterproject proposed by the railway undertaking, and identify the areas of the interoperable network, on theroute under consideration, where the trainsets should (according to this rolling stock roster project) have tobe stabled and where there are not (or not enough) stabling tracks meeting the requirements of the TSI.

Second step: the infrastructure manager and the railway undertaking carry out together an economic study,possibly leading to modifications of the rolling stock roster. Those modifications, regarding the numberand/or the location of the trainsets stabling areas, minimise the number of the new (complying with themaintenance TSI) stabling tracks that will have to be built, and also the number of already existing stablingtracks that will have to be brought into conformity with this TSI.

7.1.3.2. Water supply facilities

First step: the infrastructure manager and the railway undertaking examine together the rolling stock rosterproject proposed by the railway undertaking, and identify the areas of the interoperable network, on theroute under consideration, where the trainsets should (according to this rolling stock roster project) besupplied with water, and where there are not (or not enough) water supply facilities meeting therequirements of the TSI.

Second step: the infrastructure manager and the railway undertaking carry out together an economic studypossibly leading to modifications of the rolling stock roster. Those modifications, regarding the numberand/or the location of the areas where the trainsets will be supplied with water, minimise the number ofthe new (complying with the maintenance TSI) water supply facilities that will have to be built, and also thenumber of already existing facilities that will have to be brought into conformity with this TSI.

7.1.3.3. Mobile toilet discharge trolleys

First step: the infrastructure manager and the railway undertaking examine together the rolling stock rosterproject proposed by the railway undertaking, and identify the areas of the interoperable network, on theroute under consideration, where it should be possible (according to this rolling stock roster project) todischarge the trainsets toilets when needed, and where there are not (or not enough) toilet emptying fixedfacilities allowing this operation on those trainsets.

Second step: the infrastructure manager and the railway undertaking carry out together an economic studyleading to modifications of the rolling stock roster. Those modifications, regarding the number and/or thelocation of the areas where it will be possible to discharge the trainsets toilets when needed, minimise thenumber of mobile toilet discharge trolleys (complying with the maintenance TSI) that will have to be placedon those areas.

7.2. SPECIFIC CASES: DETAILS OF APPLICATION

(None).

7.3. RECOMMENDATION

With the aim of continually improving the water quality in the vehicles for high-speed traffic, it isrecommended that installations dealt with in point 4.2.2.2.4 be employed in such a manner that thevehicles are filled with water of a quality complying with Directive 83/18/EC. In that case, the not fixedinstallations, the hoses and nozzles, should be handled with care in order to keep water quality.


ANNEX I

SPECIFIC SITUATIONS

As specified in the TSI, the redundancies incorporated into high-speed trainsets at the design stage should enablepreventive and corrective maintenance work to be carried out mostly at the designated rolling stock maintenancedepot.

However, certain types of damage, examples of which are listed below, can lead:

� either to degraded operating modes for the rolling stock and operating restrictions (speed restriction, coachshutdowns, etc.),

� or to the need for corrective maintenance at the train terminus.

As it is important for financial reasons not to equip every terminus with special facilities, nor to tie up supplies of littleused spare parts, and in view of the difficulty of keeping staff trained for several types of rolling stock, correctivemaintenance operations should be dealt with according to one of the following four arrangements:

� basic repairs that can be carried out by train staff without any specific knowledge of the type of rolling stock,

� repairs carried out with specialist support from the home depot via a phone link,

� repairs carried out by a team from the home depot sent immediately to the spot,

� isolation of the failed component and trainset returned to base in non-commercial service.

The specific operating conditions in degraded mode or following partial or temporary repairs must be approved on acase-by-case basis according to the specifics of the rolling stock and the rules or regulations governing the working oftrains in the countries crossed (bilateral agreements required).

Examples of possible damage:

� evidence of wheel flats

� hot axle box

� seized axle

� entrance doors jammed

� air conditioning failure

� broken windows

� pantograph disabled

� toilets out of order

� faulty train control equipment (TVM, LZB, RS 4 codes�)

� horn or headlights failure

� damage to suspension spring

� damage to bogie

� damage to dampers

� damage to coupling

� trainset power supply failure

� lighting failure

� �


ANNEX II

ASSESSMENT OF CONFORMITY

ASSESSMENT OF INTEROPERABILITY CONSTITUENTS

II.1. Scope

This Annex indicates the assessment of conformity of interoperability constituents: toilet discharge system connections,trainset-interior cleaning equipment (electrical sockets) and water filling adapters of the maintenance subsystem.

II.2. Characteristics

The characteristics of the interoperability constituents to be assessed in the different phases of design and productionare marked by X in Table II.1, Table II.2 and Table II.3.

Table II.1.

Assessment of the interoperability constituent: toilet discharge system connections

1 2 3 4 5 6

Characteristics to be assessed Assessment in the following phase

Design and development phaseProduction phase

(series)Characteristic Clause Design reviewReview of

manufacturingprocess

Type test In serviceexperience

Type and dimensions 5.3.1 X n.a. n.a. n.a. X

n.a.: not applicable.

Table II.2.

Assessment of the interoperability constituent: trainset-interior cleaning equipment (electrical sockets)

1 2 3 4 5 6








Table II.3.

Assessment of the interoperability constituent: water filling adapters

1 2 3 4 5 6









ASSESSMENT OF THE MAINTENANCE SUBSYSTEM

II.3. Scope

This Annex indicates the assessment of conformity of the maintenance subsystem.

II.4. Characteristics

The characteristics of the subsystem to be assessed in the different phases of design, installation and operation aremarked by X in Tables II.4 (for fixed installations) and II.5 (for on-board installations).

Table II.4.

Assessment of the maintenance subsystem (fixed installations)

1 2 3 4 5


Design anddevelopment phase Production phase

Characteristic Clause Design review Construction, assem-bling, mounting

Assembled, beforeputting into service

Validation under fulloperation conditions

Washing machine

Height to clean 4.2.2.2.1 X n.a. n.a. X

Speed 4.2.2.2.1 X n.a. n.a. X

Mobile emptying system

Functions 4.2.2.2.2 X n.a. n.a. X

Pressure 4.2.2.2.2 X n.a. n.a. X

Compatibility with on-boardtoilets

4.2.2.2.2 X n.a. n.a. X

Stabling tracks

Length and geometricalcharacteristics

X n.a. n.a. X

Water and sand supply facilities

Quality of water 4.2.2.2.4 X n.a. n.a. X

Availability of sand 4.2.2.2.5 X n.a. n.a. X

Quality of sand 4.2.2.2.5 X n.a. n.a. X



Table II.5.

Assessment of the maintenance subsystem (on-board installations)

1 2 3 4

Characteristics to be assessed Module for assessment in the following phase

Design and development phase Production phase

Characteristic Clause Design review Type test Serial production quality

Toilet emptying

Technology of trainset toiletsallowing to be emptied at three-dayintervals

4.2.2.2.2 X n.a. n.a.

Power supply for internal cleaning

Power � Voltage 4.2.2.2.3 X X n.a.

Availability of electrical sockets 4.2.2.2.3 X n.a. n.a.

Spacing of sockets 4.2.2.2.3 X n.a. n.a.

Trainsets standby

Stationary noise level 4.2.2.2.6 X X n.a.

Capability of being stabled with nocrew aboard and with auxiliarypower supply sustained

4.2.2.2.6 X n.a. n.a.

Parking brake 4.2.2.2.6 X n.a. n.a.

n.a.: not applicable


ANNEX III

ASSESSMENT PROCEDURES (MODULES)

III.1. Module A (Internal production control)

Conformity assessment of interoperability constituents

1. This module describes the procedure whereby the manufacturer or his authorised representative establishedwithin the Community, who carries out the obligations laid down in point 2, ensures and declares that theinteroperability constituent concerned satisfies the requirements of the TSI that apply to it.

2. The manufacturer must establish the technical documentation described in point 3.

3. The technical documentation must enable the conformity of the interoperability constituent with therequirements of this TSI to be assessed. It must, as far as relevant for such assessment, cover the design,manufacture and operation of the interoperability constituent. So far as relevant for the assessment, thedocumentation must contain:

� a general description of the interoperability constituent,

� conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.,

� descriptions and explanations necessary for the understanding of said drawings and schemes and theoperation of the interoperability constituent,

� a list of the technical specifications (relevant TSI and/or European specifications with relevant clauses,referred to in the TSI), applied in full or in part,

� descriptions of the solutions adopted to meet the requirements of this TSI, where the European specificationsreferred to in the TSI have not been applied in full,

� results of design calculations made, examinations carried out, etc.,

� test reports.

4. The manufacturer must take all the measures necessary in order that the manufacturing process ensurescompliance of the manufactured interoperability constituent with the technical documentation referred to inpoint 2 and with the requirements of the TSI that apply to it.

5. The manufacturer or his authorised representative established within the Community must draw up a writtendeclaration of conformity. The content of this declaration has to include at least the information, indicated inAnnex IV(3) to Directive 96/48/EC and in Article 13(3) thereof. The EC declaration of conformity and theaccompanying documents must be dated and signed.

The declaration must be written in the same language of the technical file and must contain the following:

� the Directive reference (Directive 96/48/EC and other Directives to which the interoperability constituentmay be subject),

� the name and address of the manufacturer or his authorised representative established within the Community(give trade name and full address and in the case of authorised representative also give the trade name of themanufacturer or constructor),

� description of interoperability constituent (make, type etc.),

� description of the procedure (module) followed in order to declare conformity,

� all the relevant descriptions met by the interoperability constituent and in particular its conditions of use,

� reference to this TSI and to any other applicable TSI, and where appropriate reference to Europeanspecifications,

� identification of signatory having received power to engage the manufacturer or his authorised representativeestablished within the Community.


6. The manufacturer or his authorised representative must keep a copy of the EC declaration of conformity with thetechnical documentation for a period of 10 years after the last interoperability constituent has beenmanufactured.

Where neither the manufacturer nor his authorised representative is established within the Community, theobligation to keep the technical documentation available is the responsibility of the person who places theinteroperability constituent in the Community market.

7. If additional to the EC declaration of conformity, an EC declaration for suitability for use for the interoperabilityconstituent is required by the TSI, this declaration has to be added after being issued by the manufacturer underthe conditions of module V.

III.2. MODULE SB (EC Type-examination)

EC verification of maintenance subsystem

1. This module describes the part of EC verification procedure whereby a notified body checks and certifies at therequest of an adjudicating entity or its authorised representative established within the Community, that a type ofa maintenance subsystem, representative for the production envisaged,

� complies with this TSI and any other applicable TSI, which demonstrate that the essential requirements ofDirective 96/48/EC have been met,

� complies with the other regulations deriving from the Treaty.

2. The adjudicating entity or its authorised representative established within the Community must lodge anapplication for EC verification (through type-examination) of the subsystem with a notified body of his choice.

The application includes:

� name and address of the adjudicating entity or its authorised representative,

� the technical documentation, as described in point 3.

3. The applicant must place at the disposal of the notified body a specimen of the subsystem, representative of theproduction envisaged and hereinafter called �type�.

A type may cover several versions of the subsystem provided that the differences between the versions do notaffect the provisions of the TSI.

The notified body may request further specimens if needed for carrying out the test programme.

If so required for specific test or examination methods and specified in the TSI or in the European specificationsreferred to in Article 10 of Directive 96/48/EC, also a specimen or specimens of a subassembly or assembly or aspecimen of the subsystem in a pre-assembled condition has to be delivered.

The technical documentation must enable the design, manufacture, installation and operation of the subsystem tobe understood, and shall enable conformity with the provisions of Directive 96/48/EC and of the TSI to beassessed. It must, as far as relevant for such assessment, cover the design, manufacture and operation of thesubsystem.

It must include:

� a general description of the subsystem, overall design and structure,

� conceptual design and manufacturing drawings and schemes of components, subassemblies, assemblies,circuits, etc.,

� descriptions and explanations necessary for the understanding of said drawings and schemes and theoperation of the product,

� the technical design specifications, including European specifications, that have been applied,

� the necessary supporting evidence for their adequacy, in particular where European specifications referred toin Article 10 of Directive 96/48/EC and the relevant clauses have not been applied in full,

� a list of the interoperability constituents, to be incorporated into the subsystem,


� technical documentation as regards the manufacturing and the assembling of the subsystem,

� a list of manufacturers, involved in the subsystem's design, manufacturing, assembling and installation,

� conditions for use and maintenance of the subsystem (restrictions of running time or distance, wear limitsetc),

� a list of the European specifications referred to in Article 10 of Directive 96/48/EC or in the technical designspecification,

� results of design calculations made, examinations carried out, etc.,

� test reports.

If the TSI is requiring further information for the technical documentation, this has to be included.

4. The notified body must:

4.1. examine the technical documentation,

4.2. if a design review is requested in the TSI, perform an examination of the design methods, the design tools andthe design results to evaluate their capability to fulfil the requirements for conformity for the subsystem at thecompletion of the design process;

4.3. if type tests are requested in the TSI, verify that the specimen(s) of the subsystem or of assemblies orsubassemblies of the subsystem, required for carrying out type tests, has (have) been manufactured in conformitywith the technical documentation, and carry out or have carried out the type tests in accordance with theprovisions of the TSI and the European specifications concerned;

4.4. identify the elements which have been designed in accordance with the relevant provisions of the TSI and theEuropean Specifications referred to in Article 10 of Directive 96/48/EC, as well as the elements which have beendesigned without applying the relevant provisions of those European specifications;

4.5. perform or have performed the appropriate examinations and necessary tests in accordance with points 4.2 and4.3 to establish whether, where the relevant European specifications have been chosen, these have actuallyapplied;

4.6. perform or have performed the appropriate examinations and necessary tests in accordance with points 4.2 and4.3 to establish whether, where the adjudicating entity or the manufacturer(s) have chosen to apply the relevantEuropean specifications (standards), these have actually been applied;

4.7. agree with the applicant the location where the examinations and necessary tests will be carried out.

5. Where the type meets the provisions of Directive 96/48/EC and of the TSI, the notified body must issue atype-examination certificate to the applicant. The certificate must contain the name and address of theadjudicating entity and the manufacturer(s), conclusions of the examination, conditions for its validity and thenecessary data for identification of the approved type.

The time period of validity shall be no longer than three years.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept bythe notified body.

If the adjudicating entity or its authorised representative established within the Community is denied atype-examination certificate, the notified body must provide detailed reasons for such denial.

Provision must be made for an appeals procedure.

6. The applicant must inform the notified body that holds the technical documentation concerning the ECtype-examination certificate of all modifications to the approved subsystem which must receive additionalapproval where such changes may affect the conformity with the requirements of Directive 96/48/EC and the TSIor the prescribed conditions for use of the subsystem. This additional approval is given in the form of anaddition to the original EC type-examination certificate, or a new certificate will be issued after withdrawal of theold certificate.


7. If no modifications as under point 6 have been made, the validity of an expiring certificate can be extended foranother period of validity. The applicant applies for such a prolongation by a written confirmation that no suchmodifications have been made, and the notified body issues a prolongation for another period of validity as inpoint 5, if no contrary information is existent. This procedure can be reiterated.

8. Each notified body must communicate to the other notified bodies the relevant information concerning the ECtype-examination certificates it has withdrawn or refused.

9. The other notified bodies may receive copies of the type-examination certificates issued and/or their additions onrequest. The annexes to the certificates must be kept at the disposal of the other notified bodies.

10. The adjudicating entity or its authorised representative established within the Community must keep with thetechnical documentation copies of type-examination certificates and their additions throughout the service life ofthe subsystem, it must be sent to any other Member State who so requests.

III.3. Module SD (Production quality assurance)


1. This module describes the EC verification procedure whereby a notified body checks and certifies, at the requestof an adjudicating entity or its authorised representative established within the Community, that a maintenancesubsystem, for which an EC type-examination certificate has already been issued by a notified body,

� complies with this TSI and any other applicable TSI, which demonstrates that the essential requirements ofDirective 96/48/EC have been met,

� complies with the other regulations deriving from the Treaty and may be put into service.

The notified body is carrying out the procedure, under the condition, that the adjudicating entity and themanufacturers involved are satisfying the obligations of point 2.

2. For the subsystem, being subject of the EC verification procedure, the adjudicating entity must contract only withmanufacturers, whose activities contributing to the subsystem project to be verified (manufacturing, assembling,installation) are subject to an approved quality system for manufacture and final product inspection and testingas specified in point 3 and which shall be subject to surveillance as specified in point 4.

The term �manufacturer�, in the sense of these provisions, also includes companies:

� responsible for the whole subsystem project (including in particular responsibility for subsystem integration(main contractor)),

� performing assembling (assemblers) and installation of the subsystem.

The main contractor responsible for the whole subsystem project (including in particular responsibility forsubsystem integration), must operate in any case an approved quality system for manufacture and final productinspection and testing, as specified in point 3 and which shall be subject to surveillance as specified in point 4.

In the case, that the adjudicating entity is directly involved in the production (including assembling andinstallation), or that the adjudicating entity itself is responsible for the whole subsystem project (including inparticular responsibility for subsystem integration), it has to operate an approved quality system for thoseactivities, as specified in point 3 and subject to surveillance as specified in point 4.

3. Quality system

3.1. The manufacturer(s) involved and, if involved the adjudicating entity must lodge an application for assessment oftheir quality system with a notified body of their choice. The application must include:

� all relevant information for the subsystem envisaged,

� the quality system's documentation,

� the technical documentation of the approved type and a copy of the type-examination certificate, issued afterthe completion of the type-examination procedure of module SB.

For manufacturers, only involved in a part of the subsystem project, the information is only requested for thatspecific relevant part.


3.2. For the main contractor the quality system must ensure overall compliance of the subsystem with the type asdescribed in the type-examination certificate and overall compliance of the subsystem with the requirements ofthe TSI. For other manufacturers (subsuppliers) the quality system has to ensure compliance of their relevantcontribution to the subsystem with the type as described in the type-examination certificate and with therequirements of the TSI.

All the elements, requirements and provisions adopted by the applicants must be documented in a systematicand orderly manner in the form of written policies, procedures and instructions. This quality systemdocumentation shall ensure a common understanding of the quality policies and procedures such as qualityprogrammes, plans, manuals and records.

It must contain in particular an adequate description of the following items for all applicants:

� the quality objectives and the organisational structure,

� the corresponding manufacturing, quality control and quality assurance techniques, processes and systematicactions that will be used,

� the examinations, the checking and tests that will be carried out before, during and after manufacture,assembling and installation and the frequency with which they will be carried out,

� the quality records, such as inspection reports and test data, calibration data, qualification reports of thepersonnel concerned, etc., and for the main contractor,

� responsibilities and powers of the management with regard to overall subsystem quality, including inparticular the subsystem integration management.

The examinations, tests and checking shall cover all of the following stages:

� structure of subsystem, including, in particular, civil-engineering activities, constituent assembly, finaladjustment,

� final testing of the subsystem,

� and, where specified in the TSI, the validation under full operation conditions.

3.3. The notified body referred to in point 3.1. must assess the quality system to determine whether it satisfies therequirements referred to in point 3.2. It shall presume compliance with these requirements in respect of qualitysystems that implement the relevant harmonised standard. This harmonised standard shall be EN ISO 9001 �December 2000, completed if necessary to take into consideration the specificity of the subsystem for which it isimplemented.

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of theapplicant to the subsystem. The auditing team must have at least one member experienced as an assessor in thesubsystem technology concerned. The evaluation procedure shall include an assessment visit to the applicant'spremises.

The decision must be notified to the applicant. The notification must contain the conclusions of the examinationand the reasoned assessment decision.

3.4. The manufacturer(s) and if involved the adjudicating entity must undertake to fulfil the obligations arising out ofthe quality system as approved and to uphold it so that it remains adequate and efficient.

They must keep the notified body that has approved the quality system informed of any intended updating of thequality system.

The notified body must evaluate the modifications proposed and decide whether the amended quality system willstill satisfy the requirements referred to in point 3.2 or whether a re-assessment is required.

It must notify its decision to the applicant. The notification shall contain the conclusions of the examination andthe reasoned assessment decision.

4. Surveillance of the quality system(s) under the responsibility of the notified body(ies)


4.1. The purpose of surveillance is to make sure that the manufacturer(s) and, if involved the adjudicating entity dulyfulfil the obligations arising out of the approved quality system.

4.2. The notified body as referred to in point 3.1 must have permanent access for inspection purposes to thelocations of building sites, production workshops, locations of assembling and installation, storage areas and,where appropriate, prefabrication or testing facilities and, more general, to all premises which it considersnecessary for its task, in accordance with the applicant's specific contribution to the subsystem project.

4.3. The manufacturer(s) and, if involved the adjudicating entity or its authorised representative established within theCommunity must send the notified body referred to point 3.1 (or have sent it) all the documents needed for thatpurpose and in particular the implementation plans and technical records concerning the subsystem (as far asrelevant for the specific contribution of the applicant to the subsystem), in particular:

� the quality system documentation, including the particular means implemented to ensure that:

� (for the main contractor) overall responsibilities and powers of the management for the compliance ofthe whole entire subsystem are sufficiently and properly defined,

� the quality systems of each manufacturer are correctly managed for achieving integration at subsystemlevel,

� the quality records as foreseen by the manufacturing part (including assembling and installation) of thequality system, such as inspection reports and test data, calibration data, qualification reports of thepersonnel concerned, etc.

4.4. The notified body(ies) must periodically carry out audits to make sure that the manufacturer(s) and, if involvedthe adjudicating entity maintain and apply the quality system and must provide an audit report to them.

The frequency of the audits shall be at least once a year, with at least one audit during the time period ofperforming relevant activities (manufacture, assembling or installation) for the subsystem being the subject of theEC verification procedure mentioned in point 6.

4.5. Additionally the notified body(ies) may pay unexpected visits to the sites mentioned in point 4.2. of theapplicant(s). At the time of such visits, the notified body may conduct complete or partial audits and may carryout or cause to be carried out tests, in order to check the proper functioning of the quality system wherenecessary. It must provide the applicant(s) with an inspection report and also, if an audit has been carried out,with an audit report, and, if a test has been carried out with a test report.

5. The manufacturer(s) and, if involved the adjudicating entity must, for a period of 10 years after the lastsubsystem has been manufactured, keep at the disposal of the national authorities:

� the documentation referred to in the second indent of the second subparagraph of point 3.1,

� the updating referred to in the second subparagraph of point 3.4,

� the decisions and reports from the notified body which are referred to in the final subparagraph of point3.4, points 4.4 and 4.5.

6. EC verification procedure

6.1. The adjudicating entity or its authorised representative established within the Community must lodge anapplication for EC verification of the subsystem (through production quality assurance), including coordination ofthe surveillance of the quality systems as in point 6.5, with a notified body of its choice. The adjudicating entityor his authorised representative within the Community must inform the manufacturers involved of this choiceand of the application.

6.2. The application must enable the design, manufacture, assembling, installation and operation of the subsystem tobe understood, and shall enable conformity with the requirements of Directive 96/48/EC and the TSI to beassessed.


It must include:

� the technical documentation regarding the approved type, including the type-examination certificate, asissued after completion of the procedure defined in module SB, and, if not included in this documentation,


� the necessary supporting evidence for their adequacy, in particular where the European specificationsreferred to in Article 10 of Directive 96/48 have not been applied in full. This supporting evidence mustinclude the results of tests carried out by the appropriate laboratory of the manufacturer or on hisbehalf,

� the technical documentation as regards the manufacturing and the assembling of the subsystem,


� a list of all manufacturers, involved in the subsystem's design, manufacturing, assembling and installation,

� the demonstration, that all stages, as mentioned in point 3.2, are covered by quality systems of themanufacturers and/or of the adjudicating entity involved and the evidence of their effectiveness,

� indication of the notified body(ies), responsible for the approval and surveillance of these quality systems.

6.3. The notified body must examine the application concerning the validity of the type-examination and thetype-examination certificate.

6.4. The notified body must then examine, if all stages of the subsystem as mentioned in the last subparagraph ofpoint 3.2 are sufficiently and properly covered by the approval and surveillance of the quality system(s) of theapplicant(s).

If the conformity of the subsystem with the type as described in the EC type-examination certificate and thecompliance of the subsystem with the requirements of Directive 96/48/EC and the TSI is based on more thanone quality system, it has to examine in particular,

� if the relations and interfaces between the quality systems are clearly documented, and

� if overall responsibilities and powers of the management for the compliance of the whole entire subsystemfor the main contractor are sufficiently and properly defined.

6.5. The notified body responsible for the EC verification, if not carrying out the surveillance of the quality system(s)concerned as in point 4, must coordinate the surveillance activities of any other notified body responsible forthat task, in order to be ensured that correct management of interfaces between the different quality systems inview of subsystem integration has been performed. This coordination includes the right of the notified bodyresponsible for the EC verification,

� to receive all documentation (approval and surveillance), issued by the other notified body(ies),

� to witness the surveillance audits as under point 4.4,

� to initiate additional audits as under point 4.5 under its responsibility and together with the other notifiedbody(ies).

6.6. Where the subsystem meets the requirements of Directive 96/48/EC and the TSI, the notified body must then,based on the type-examination and the approval and surveillance of the quality system(s), draw up the certificateof EC verification intended for the adjudicating entity or its authorised representative established within theCommunity, which in turn draws up the EC declaration of verification intended for the supervisory authority inthe Member State within which the subsystem is located and/or operates.

The EC declaration of verification and the accompanying documents must be dated and signed. The declarationmust be written in the same language of the technical file and must contain at least the information included inAnnex V to Directive 96/48/EC.

6.7. The notified body shall be responsible for compiling the technical file that has to accompany the EC declarationof verification. The technical file has to include at least the information indicated in Article 18(3) of Directive96/48/EC, and in particular as follows:


� all necessary documents relating to the characteristics of the subsystem,

� list of interoperability constituents incorporated into the subsystem,

� copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability foruse, which said constituents must be provided in accordance with Article 13 of the Directive, accompanied,where appropriate, by the corresponding documents (certificates, quality system approval and surveillancedocuments) issued by the notified bodies on the basis of the TSI,

� all elements relating to the conditions and limits for use,

� all elements relating to the instructions concerning servicing, constant or routine monitoring, adjustment andmaintenance,

� the EC type-examination certificate for the subsystem and the accompanying technical documentation,

� certificate of EC verification of the notified body as mentioned in point 6.5, accompanied by correspondingcalculation notes and countersigned by itself, stating that the project complies with the Directive 96/48/ECand the TSI, and mentioning, where appropriate, reservations recorded during performance of the activitiesand not withdrawn; the certificate should also be accompanied by the inspection and audit reports drawn upin connection with the verification, as mentioned under points 4.4 and 4.5 and in particular.

7. The complete records accompanying the certificate of EC verification must be lodged with the adjudicating entityor its authorised representative in support of the certificate of EC verification issued by the notified body andmust be attached to the EC declaration of verification drawn up by the adjudicating entity intended for thesupervisory authority.

8. The adjudicating entity or its authorised representative within the Community must keep a copy of the recordsthroughout the service life of the subsystem; it must be sent to any other Member State who so requests.

III.4. Module SF (product verification)


1. This module describes the EC verification procedure whereby a notified body checks and certifies at the requestof an adjudicating entity or its authorised representative established within the Community, that a maintenancesubsystem, for which already a EC type-examination certificate has been issued by a notified body,



2. The adjudicating entity or its authorised representative established within the Community must lodge anapplication for EC verification (through product verification) of the subsystem with a notified body of his choice.



� the technical documentation.

3. Within that part of the procedure the adjudicating entity or his authorised representative established within theCommunity checks and attests that the subsystem concerned is in conformity with the type as described in theEC type-examination certificate and satisfies the requirements of the Directive 96/48/EC and the TSI that apply tothem.

4. The adjudicating entity must take all measures necessary in order that the manufacturing process (includingassembling and integration of interoperability constituents) ensures conformity of the subsystem with the type asdescribed in the EC type-examination certificate and with the requirements of the TSI that apply to them.

5. The technical documentation must enable the design, manufacture, installation and operation of the subsystem tobe understood, and shall enable conformity with the type as described in the type-examination certificate and therequirements of the Directive and the TSI to be assessed.


It must include:

� the type-examination certificate and its accompanying documents and additions, and, as far as not includedin the documents accompanying the EC type-examination certificate,


� conceptual design and manufacturing drawings and schemes of subassemblies, circuits, etc.,


� the technical design specifications, including European specification, that have been applied,

� the necessary supporting evidence for their adequacy, in particular where European specification have notbeen applied in full,



� a list of the European specification If the TSI is requiring further information for the technicaldocumentation, this has to be included.

6. The notified body must carry out the appropriate examinations and tests in order to check the conformity of thesubsystem with the type as described in the EC type-examination certificate and with the requirements ofDirective 96/48/EC and the TSI by examination and testing of every subsystem, manufactured as a serial product,as specified under Point 4.

7. Verification by examination and testing of every subsystem (as a serial product).

7.1. The notified body must carry out the tests, examinations and verifications, to ensure conformity subsystem asserial products with the essential requirements of the Directive and of the TSI. The examinations, tests andchecking shall extend to the following stages as provided for in the TSI:

� structure of subsystem, including constituent assembly and overall adjustments,


� and, whenever specified in the TSI, the validation under full operational conditions.

7.2. All subsystems (as serial products) must be individually examined and appropriate tests and verifications as setout in the TSI and in the relevant European Specifications (or equivalent tests) shall be carried out in order toverify their conformity with the type as described in the type-examination certificate and the requirements of theTSI that apply to them.

8. The notified body may agree with the adjudicating entity the locations where the tests will be carried out andmay agree that final testing of the subsystem and, whenever required in the TSI, tests or validation under fulloperating conditions, are carried out by the adjudicating entity under direct supervision and attendance of thenotified body.

9. The notified body must have permanent access for testing and verification purposes to production workshops,locations of assembling and installations, and where appropriate, prefabrication and testing facilities in order tocarry out its tasks as provided for in the TSI.

10. Where the subsystem meets the requirements of Directive 96/48/EC and the TSI, the notified body must then,based on the tests, verifications and checking carried out on all serial products as indicated in point 7, andrequired in the TSI and in the European specification referred to in Article 10 of Directive 96/48/EC, draw upthe certificate of EC verification intended for the adjudicating entity or its authorised representative establishedwithin the Community, which in turn draws up the EC declaration of verification intended for the supervisoryauthority in the Member state where the subsystem is located and/or operates. The EC declaration of verificationand the accompanying documents must be dated and signed. The declaration must be written in the samelanguage of the technical file and must contain at least the information included in Annex V of Directive96/48/EC.


11. The notified body shall be responsible for compiling the technical file that has to accompany the EC declarationof verification. The technical file has to include at least the information indicated in Article 18(3) of Directive96/48/EC, and in particular as follows:




� all elements relating to conditions and limits for use,


� EC type-examination certificate and accompanying technical documentation,

� certificate of EC verification of the notified body as mentioned under point 10, accompanied bycorresponding calculation notes and countersigned by itself, stating that the project complies with theDirective and the TSI, and mentioning, where appropriate, reservations recorded during performance ofactivities and not withdrawn; the certificate should also be accompanied, if relevant, by the inspection andaudit reports drawn up in connection with the verification.



III.5. Module SG (Unit verification)


1. This module describes the EC verification procedure whereby a notified body checks and certifies, at the requestof an adjudicating entity or its authorised representative established within the Community, that a maintenancesubsystem:



2. The adjudicating entity or its authorised representative established within the Community must lodge anapplication for EC verification (through unit verification) of the subsystem with a notified body of his choice.



� the technical documentation.

3. The technical documentation must enable the design, manufacture, installation and operation of the subsystem tobe understood, and shall enable conformity with the requirements of the TSI to be assessed.

It must include:


� conceptual design and manufacturing drawings and schemes of subassemblies, circuits, etc.,




� the necessary supporting evidence for their adequacy, in particular where European specifications referred toin the TSI and the relevant clauses have not been applied in full,



� a list of the European specifications referred to in the TSI or in the technical design specification.

If the TSI is requiring further information for the technical documentation, this has to be included.

4. The notified body must examine the application, and carry out the appropriate tests and verifications as set outin the TSI and/or in the European specifications referred to in the TSI, to ensure conformity with the essentialrequirements of the Directive as provided for in the TSI. The examinations, tests and checking shall extend to thefollowing stages as provided for in the TSI:

� overall design,

� structure of subsystem, including, in particular and when relevant, civil-engineering activities, constituentassembly, overall adjustments,


� and, whenever specified in the TSI, the validation under full operational conditions.

5. The notified body may agree with the adjudicating entity the locations where the tests will be carried out andmay agree that final subsystem tests and, whenever required in the TSI, tests in full operating conditions, arecarried out by the adjudicating entity under direct supervision and attendance of the notified body.

6. The notified body must have permanent access for testing and verification purposes to the locations of design,building sites, production workshops, locations of assembling and installations, and where appropriate,prefabrication and testing facilities in order to carry out its tasks as provided for in the TSI.

7. Where the subsystem meets the requirements of the TSI, the notified body must then, based on the tests,verifications and checking carried out as required in the TSI and in the European specifications referred to in theTSI, draw up the certificate of EC verification intended for the adjudicating entity or its authorised representativeestablished within the Community, which in turn draws up the EC declaration of verification intended for thesupervisory authority in the Member State where the subsystem is located and/or operates. The EC declaration ofverification and the accompanying documents must be dated and signed. The declaration must be written in thesame language of the technical file and must contain at least the information included in Annex V to Directive96/48/EC.

8. The notified body shall be responsible for compiling the technical file that has to accompany the EC declarationof verification. The technical file has to include at least the information indicated in Article 18(3) of Directive96/48/EC, and in particular as follows:




� all elements relating to conditions and limits for use,


� certificate of EC verification of the notified body as mentioned in point 7, accompanied by correspondingcalculation notes and countersigned by itself, stating that the project complies with the Directive and the TSI,and mentioning, where appropriate, reservations recorded during performance of activities and notwithdrawn; the certificate should also be accompanied, if relevant, by the inspection and audit reports drawnup in connection with the verification.




III.6. Module SH2 (Full quality assurance with design examination)


1. This module describes the EC verification procedure whereby a notified body checks and certifies, at the requestof an adjudicating entity or its authorised representative established within the Community, that a maintenancesubsystem:



The notified body is carrying out the procedure, including a design examination of the subsystem under thecondition, that the adjudicating entity and the manufacturers involved are satisfying the obligations of point 2.

2. For the subsystem, being subject of the EC verification procedure, the adjudicating entity must contract only withmanufacturers, whose activities contributing to the subsystem project to be verified (design, manufacturing,assembling, installation) are subject to an approved quality system for design, manufacture and final productinspection and testing as specified in point 3 and which shall be subject to surveillance as specified in point 4.

The term �manufacturer� also includes companies:

� responsible for the whole subsystem project (including in particular responsibility for subsystem integration(main contractor),

� performing design services or studies (e.g. consultants),

� performing assembling (assemblers) and installation of the subsystem. For manufacturers, performing onlyassembling and installation, a quality system for manufacture and final product inspection and testing issufficient.

The main contractor responsible for the whole subsystem project (including in particular responsibility forsubsystem integration), must operate in any case an approved quality system for design, manufacture and finalproduct inspection and testing, as specified in point 3 and which shall be subject to surveillance as specified inpoint 4.

In the case that the adjudicating entity is directly involved in the design and/or production (including assemblingand installation), or that the adjudicating entity itself is responsible for the whole subsystem project (including inparticular responsibility for subsystem integration), it has to operate an approved quality system for thoseactivities, as specified in point 3 and subject to surveillance as specified in point 4.

3. Quality system

3.1. The manufacturer(s) involved and, if involved, the adjudicating entity must lodge an application for assessment oftheir quality system with a notified body of their choice.

The application must include:

� all relevant information for the subsystem envisaged,

� the quality system's documentation.

For manufacturers, only involved in a part of the subsystem project, the information is only requested for thatspecific relevant part.


3.2. For the main contractor the quality system must ensure overall compliance of the subsystem with therequirements of Directive 96/48/EC and the TSI. For other manufacturers (subsuppliers) the quality system has toensure compliance of their relevant contribution to the subsystem with the requirements of the TSI.

All the elements, requirements and provisions adopted by the applicants must be documented in a systematicand orderly manner in the form of written policies, procedures and instructions. This quality systemdocumentation shall ensure a common understanding of the quality policies and procedures such as qualityprogrammes, plans, manuals and records.

It must contain in particular an adequate description of the following items for all applicants:

� the quality objectives and the organisational structure,

� the corresponding manufacturing, quality control and quality assurance techniques, processes and systematicactions that will be used,

� the examinations, the checking and tests that will be carried out before, during and after manufacture,assembling and installation and the frequency with which they will be carried out,

� the quality records, such as inspection reports and test data, calibration data, qualification reports of thepersonnel concerned, etc.,

for the main contractor and for the subsuppliers (only as far as relevant for their specific contribution to thesubsystem project):

� the technical design specifications, including European specifications, that will be applied and, where theEuropean specifications referred to in Article 10 of Directive 96/48/EC will not be applied in full, the meansthat will be used to ensure that the requirements of the TSI that apply to the subsystem will be met,

� the design control and design verification techniques, processes and systematic actions that will be usedwhen designing the subsystem,

� the means to monitor the achievement of the required design and subsystem quality and the effectiveoperation of the quality system,

and for the main contractor:

� responsibilities and powers of the management with regard to overall design and subsystem quality,including in particular the subsystem integration management.

The examinations, tests and checking shall cover all of the following stages:

� overall design,

� structure of subsystem, including, in particular, civil-engineering activities, constituent assembly, finaladjustment,


� and, where specified in the TSI, the validation under full operation conditions.

3.3. The notified body referred to in point 3.1 must assess the quality system to determine whether it satisfies therequirements referred to in point 3.2. It shall presume compliance with these requirements in respect of qualitysystems that implement the relevant harmonised standard. This harmonised standard shall be EN ISO 9001 �December 2000, completed if necessary to take into consideration the specificity of the subsystem for which it isimplemented.

For applicants, which are only involved in assembling and installation, the harmonised standard shall be EN ISO9001 � December 2000, completed if necessary to take into consideration the specificity of the subsystem forwhich it is implemented.

The audit shall be specific for the subsystem concerned, taking into consideration the specific contribution of theapplicant to the subsystem. The auditing team must have at least one member experienced as an assessor in thesubsystem technology concerned. The evaluation procedure shall include an assessment visit to the applicant'spremises.

The decision must be notified to applicant. The notification must contain the conclusions of the examination andthe reasoned assessment decision.


3.4. The manufacturer(s) and, if involved the adjudicating entity must undertake to fulfil the obligations arising out ofthe quality system as approved and to uphold it so that it remains adequate and efficient.

They must keep the notified body that has approved their quality system informed of any intended updating ofthe quality system.

The notified body must evaluate the modifications proposed and decide whether the amended quality system willstill satisfy the requirements referred to in point 3.2 or whether a reassessment is required.

It must notify its decision to the applicant. The notification shall contain the conclusions of the examination andthe reasoned assessment decision.

4. Surveillance of the quality system(s) under the responsibility of the notified body(ies)

4.1. The purpose of surveillance is to make sure that the manufacturer(s) and if involved the adjudicating entity dulyfulfil the obligations arising out of the approved quality system.

4.2. The notified body(ies) as referred to in point 3.1 must have permanent access for inspection purposes to thelocations of design, building sites, production workshops, locations of assembling and installation, storage areasand, where appropriate, prefabrication or testing facilities and, more general, to all premises which it considersnecessary for its task, in accordance with the applicant's specific contribution to the subsystem project.

4.3. The manufacturer(s) and, if involved the adjudicating entity or its authorised representative established within theCommunity must send the notified body referred to under point 3.1. (or have sent it) all the documents neededfor that purpose and in particular the implementation plans and technical records concerning the subsystem (asfar as relevant for the specific contribution of the applicant to the subsystem), in particular:

� the quality system documentation, including the particular means implemented to ensure that:

� (for the main contractor) overall responsibilities and powers of the management for the compliance ofthe whole entire subsystem are sufficiently and properly defined,

� the quality systems of each manufacturer are correctly managed for achieving integration at subsystemlevel,

� the quality records as foreseen by the design part of the quality system, such as results of analyses,calculations, tests, etc.,

� the quality records as foreseen by the manufacturing part (including assembling and installation) of thequality system, such as inspection reports and test data, calibration data, qualification reports of thepersonnel concerned, etc.

4.4. The notified body(ies) must periodically carry out audits to make sure that the manufacturer(s) and, if involvedthe adjudicating entity maintain and apply the quality system and shall provide an audit report to them.

The frequency of the audits shall be at least once a year, with at least one audit during the time period ofperforming relevant activities (design, manufacture, assembling or installation) for the subsystem being thesubject of the EC verification procedure mentioned in point 6.

4.5. Additionally the notified body(ies) may pay unexpected visits to the sites mentioned in point 4.2. of theapplicant(s). At the time of such visits, the notified body may conduct complete or partial audits. in order tocheck the proper functioning of the quality system where necessary; it must provide the applicant(s) with aninspection report and, if an audit has been carried out, with an audit report.

5. The manufacturer(s) and, if involved the adjudicating entity must, for a period of 10 years after the lastsubsystem has been manufactured, keep at the disposal of the national authorities:

� the documentation referred to in the second indent of the second subparagraph of point 3.1,

� the updating referred to in the second subparagraph of point 3.4,

� the decisions and reports from the notified body which are referred to in the final subparagraph of point3.4, points 4.4 and 4.5.


6. EC verification procedure

6.1. The adjudicating entity or its authorised representative established within the Community must lodge anapplication for EC verification of the subsystem (through full quality assurance with design examination),including coordination of surveillance of the quality systems as in points 4.4 and 4.5, with a notified body of itschoice. The adjudicating entity or its authorised representative established within the Community must informthe manufacturers involved of his choice and of the application.

6.2. The application must enable the design, manufacture, installation and operation of the subsystem to beunderstood, and shall enable conformity with the requirements of the TSI to be assessed.

It must include:


� the necessary supporting evidence for their adequacy, in particular where the European specificationsreferred to in the TSI have not been applied in full. This supporting evidence must include the results of testscarried out by the appropriate laboratory of the manufacturer or on his behalf.

� the technical documentation as regards the manufacturing and the assembling of the subsystem,


� a list of all manufacturers, involved in the subsystem's design, manufacturing, assembling and installation,

� the demonstration, that all stages, as mentioned under point 3.2, are covered by quality systems of themanufacturer(s) and/or of the adjudicating entity involved, and the evidence of their effectiveness,

� indication of the notified body(ies), responsible for the approval and surveillance of these quality systems.

6.3. The notified body must examine the application concerning the design examination and where the design meetsthe provisions of the Directive 96/48/EC and of the TSI that apply to it must issue a design examination reportto the applicant. The report shall contain the conclusions of the design examination, conditions for its validity,the necessary data for identification of the design examined and, if relevant, a description of the subsystem'sfunctioning.

6.4. The notified body must, concerning the other stages of the EC verification, examine if all stages of the subsystemas mentioned in point 3.2 are sufficiently and properly covered by the approval and surveillance of qualitysystem(s).

If the compliance of the subsystem with the requirements of the TSI is based on more than one quality system, ithas to examine in particular:

� if the relations and interfaces between the quality systems are clearly documented,

� and if overall responsibilities and powers of the management for the compliance of the whole entiresubsystem for the main contractor are sufficiently and properly defined.

6.5. The notified body responsible for the EC verification, if not carrying out the surveillance of the quality system(s)concerned as in point 4, must coordinate the surveillance activities of any other notified body responsible forthat task, in order to be ensured that correct management of interfaces between the different quality systems inview of subsystem integration has been performed. This coordination includes the right of the notified bodyresponsible for the EC verification:

� to receive all documentation (approval and surveillance), issued by the other notified body(s),

� to witness the surveillance audits as in point 4.4,

� to initiate additional audits as in point 4.5 under its responsibility and together with the other notifiedbody(s).


6.6. Where the subsystem meets the requirements of Directive 96/48/EC and the TSI, the notified body must then,based on the design examination and the approval and surveillance of the quality system(s), draw up thecertificate of EC verification intended for the adjudicating entity or its authorised representative established withinthe Community, which in turn draws up the EC declaration of verification intended for the supervisory authorityin the Member State within which the subsystem is located and/or operates.

The EC declaration of verification and the accompanying documents must be dated and signed. The declarationmust be written in the same language of the technical file and must contain at least the information included inAnnex V of Directive 96/48/EC.

6.7. The notified body shall be responsible for compiling the technical file that has to accompany the EC declarationof verification. The technical file has to include at least the information indicated in Directive 96/48/EC, Article18(3), and in particular as follows:




� all elements relating to the conditions and limits for use,


� certificate of EC verification of the notified body as mentioned in point 6.6, accompanied by correspondingcalculation notes and countersigned by itself, stating that the project complies with the Directive and the TSI,and mentioning, where appropriate, reservations recorded during performance of the activities and notwithdrawn, the certificate should also be accompanied by the inspection and audit reports drawn up inconnection with the verification, as mentioned in points 4.4 and 4.5.




12.9.2002L

245/35O

fficialJournalofthe

EuropeanCom

munities

ENANNEX IV

CONNECTIONS FOR THE TOILET DISCHARGE SYSTEM

3¢ Connection of evacuation and 1¢ Connection for flushing (outer parts)

A B C D E F G

3¢ connection 92,20 104 55 7,14 4 82,55 133,3

1¢ connection 37,24 40,5 37,5 7,14 2,4 44,45 65

Material: stainless steel General tolerances ± 0,1

Figure 1

Joints

A B C

3¢ joint 94,45 76,20 6,35

1¢ joint 39,69 26,98 6,35

General tolerances ± 0,1

Material: Elastomer, faeces-resistant e.g. FPM (fluor rubber)

Figure 2

ANNEX V

INLET CONNECTIONS FOR WATER TANKS

Inlet connections for water tanks

` = Obligatory

Figure 3


COMMISSION - Transportstyrelsen

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